Quality Regulatory Engineer BOLOGNA

Quality Regulatory Engineer
Bologna
Emilia Romagna, BOLOGNA

The Quality Regulatory Engineer is responsible for supporting engineers and development activities by sharing regulatory requirements, providing time and cost estimations to achieve the approvals for the list of countries defined, checking samples before regulatory submission, and preparing documentation for regulatory submissions.

He/She monitors the activities with the Agencies involved in certification processes and follows up on regulatory topics related to new product development, maintenance, and renewals of expiring certifications.

In Datalogic, the new product development is managed through a gating process called NPD (New Product Development).

During NPD, periodical meetings are held (CTM = Core Team Meetings and Technical Meetings) to exchange information among teams involved in the projects.

Key Responsibilities: Request quotations and timings from Regulatory Agencies / Certification Laboratories to achieve certifications.

Cooperate with them to get the test plan, including the number of samples required and how to be prepared. Support the development department to guarantee compliance with applicable regulations. Attend regular Core Team Meetings and Technical Meetings (when necessary) to support new product development. Prepare documentation needed for NPD stages. Verify test reports and certificates received from Regulatory Agencies / Certification Laboratories. Share with the CTM the completion of activities and provide actual costs and times versus previously communicated estimations at the end of the process. Keep certifications updated and renew them before the expiration date. Share compliance and regulatory documentation with requestors when needed. Qualifications / Requirements: Education: Degree in Electronic or Automation Engineering or similar. Experience: Minimum of four years of experience in Product Quality or a related field.

Past experience in Regulatory Topics in I. T. E. , and basic knowledge of EMC is preferable. Other Information and Specific Skills:- Work experience and training in type approval certifications.

- Knowledge of European directives for CE conformity declaration (Low Voltage Directive, EMC, Radio Equipment Directive, NAWI Directive, RoHS, REACH).

- Knowledge of International Regulatory requirements (USA/Canada, Australia, New Zealand, Japan, South Korea, Taiwan, China).

- Proficiency in Office tools.

- Capability to work in a team and to sustain strong positions.

- Capability to work under pressure.

- Availability for occasional National or International trips.

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